Long-Term Assessment of Quality of Life and Effectiveness of Onabotulinumtoxina Injections in Provoked Vestibulodynia

The study aims to assess and compare the pain in women suffering from provoked vestibulodynia, before treatment with botulinum injections, 3 months after treatment and 18 months after treatment.

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Key information

Conditions

Vestibulodynia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases Vulvar Diseases Vulvodynia

Age range

18 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

CHU Besançon

Besançon, 25000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Vestibulodynia rated B2 according to 2003 International Society for the Study of Vulvovaginal Disease (ISSVD) classification
Patients previously treated no later than18 months ago for provoked vestibulodynia with botulinum toxin injections, in the University Hospital of Besançon.

Exclusion criteria

Major psychologic disorders.

Treatment and study plan

Primary outcomes

Long-term pain improvement after botulinum toxin injections

Time frame: 18 months

Assessment and comparison of pain using Visual Analogic Scale values before treatment,3 months after treatment and 18 months after treatment.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Acronym: QUALVESTO

Important dates

Study start: 2013
Primary completion: 2013
Study completion: 2013
First posted: Aug 8, 2016
Registry last updated: Aug 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed